Lovin' It
I don't know what you thought my post was insinuating but I was simply pointing out the incorrect of the word approval in your post. If you think I was suggesting it was intentional to mislead people, I think that might be a bit of a reach.Once again I reiterate in my post I simply made a grammatical error, a mistake, a misprint. Though I feel your apparent insinuation was unwarranted given my previous analysis on the topic. For if you had taken time to read my countless posts over recent months you would have read such lines or phrases as:
As with Azer Cel Vaxinia has recently obtained support from the FDA, in receiving fast track designation and priority review status,
Approximately 100 days later the FDA approved a fast track designation and priority review status for the bile duct indication. They obviously deemed the Vaxinia results as significant.
“Our near term goal is to attain a Fast Track designation and Priority Review for one or of these abc gastrointestinal indications. Our intermediate goal is to achieve a registration trial for these gastrointestinal cancer indications, with our long term goal being to obtain FDA approval and eventually market share in these gastrointestinal solid tumour markets.
As for your ardent supporter 2 dollars who is clearly disappointed they missed out on IMU at 2 cents, just as they appear well and truly annoyed with all those smart enough to get in, the facts are just so wonderful, and I repeat,
Imugene personnel have 14 FDA product approvals between them (cc Jakob Dupont and LC).
One other factor pointing toward an ultimate approval for Vaxinia is as posted on https://www.centerwatch.com in recent years is the fact that:
“The success rates for Fast Track applications submitted to FDA’sCenter for Drug Evaluation and Research (CDER) have ranged between 70% and 80% over the last three years.”
There are people screaming from the rooftops clearly either hoping or perhaps looking for Vaxinia to fail. But the odds are stacking in favour of a VAXINIA FDA Approval. Fast track designations and priority review status clearly give you the inside track with the FDA, it's yours to lose. The figures speak for themselves. 7 out of 10 aren't bad odds for those with an appetite for risk. But as noted nothings a certainty. It ain't over til the Fat Lady Sings.
Thx @mmc4 btw, your sentiment sums up my sentiment 2atee. I really appreciated reading your post tonight when out walking the dog. It makes telling the story all the more worthwhile. The bottom line is noone knows the outcome when it comes to either Vaxinia or Imugene. In months to come the drug could FAIL and stock could FALL in a messy heap back to 1.7 cents, as it was when many first hopped on the train. But it's kind of nice to stand behind and support the tireless hours spent from company innovators and professionals, To throw your hard earned behind those who live and die by the noble quest to cure cancer. To me that kind defies all cynicism, wouldn't you agree.
DYOR
P.S Given we are now approaching the pointy end of proceedings, please forgive me, but I'm stepping away from my previously balanced approach toward IMU for the next 30 DAYS ONLY to one of UPRAMPING. I'm contemplating establishing an IMU CHEER SQUAD THREAD for all those interested. Should we make it via invite only? It doesn't give you free admission to the dollar party in Noosa, but it gets you to the door.
References :
https://www.imugene.com/news/2023/11/28/fda-fast-track-designation-for-bile-duct-cancer-granted-for-cf33-hnis-vaxinia-mast-clinical-program
https://www.mskcc.org
https://www.cityofhope.org
https://www.osu.edu
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
https://www.imugene.com/news/2022/9/7/imugene-appoints-industry-and-drug-development-expert-dr-jakob-dupont-as-non-executive-director
https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review
(20min delay)